While the West and Japan are prioritizing personalized medicine and the use of Companion Diagnostics (CDx) to determine which patients will benefit from specific drugs, development in China has been slow. In China, CDx products are classified and regulated by existing medical device or IVD regulations. Recent guidelines for CDX products in China are listed below:
- Guidelines for Technical Review and IFU Update of Tumor Companion Diagnostic Reagents Based on Similar Treatment Drugs
- Guidelines for Registration Review of Clinical Trial of Non-Original Companion Diagnostic Reagents (CDx) of Anti-tumor Drugs
- Guidelines for Registration Review of Original Companion Diagnostic Reagents Co-developed (simultaneously) with Anti-tumor Drugs
To date, CDx products in China have been geared toward cancer treatments. Guidelines recommend that cancer drugs and the related CDx product be developed simultaneously. While there have been a number of CDx articles posted on the CMDE website, and publications discussing CDx products, the NMPA has still not published any official CDx regulations. Well-known CDx companies like Foundation One and Myriad Genetics do not seem to be in the China marketplace yet.